Identity
- Trade Name
- IF Sprinter (model IFA/ELISA with ReSa-Trax) FDA UDI
- Generic Name
- Enzyme immunoassay (EIA) analyser IVD FDA UDI
- Model / Reference
- YG 0032-0101-3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049016100607 FDA UDI
- FDA Product Code
- JJE FDA UDI
- GMDN Term
- Enzyme immunoassay (EIA) analyser IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2160 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
IF Sprinter (model IFA/ELISA with ReSa-Trax) by EUROIMMUN Medizinische Labordiagnostika AG — Class I — FDA UDI — listed in FDA GUDID
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- EUROIMMUN Medizinische Labordiagnostika AG
Sources (1)
- FDA UDI e5184398-3ac5-4ce8-8706-57893f87042e 33 fields · synced Jun 7, 2026